FDA Clears New CDC Test to Detect Human Influenza

The U.S. Food and Drug Administration (FDA) today cleared a new test developed by the U.S. Centers for Disease Control and Prevention (CDC)to diagnose human influenza infections and the highly pathogenic influenza A (H5N1) viruses. The device, called the Human Influenza Virus Real-Time RT-PCR Detection and Characterization Panel (rRT-PCR Flu Panel), uses a molecular biology technique to detect flu virus and differentiate between seasonal and novel influenza. The device is used to isolate and amplify viral genetic material present in secretions taken from a patient's nose or throat. The viral genetic material is labeled with fluorescent molecules, which are then detected and analyzed by a diagnostic instrument called the Applied Biosystems7500 Fast Dx, also cleared today by the FDA for diagnostic use simultaneously with the CDC's rRT-PCR Flu Panel. The test panel and diagnostic system can detect and identify commonly circulating human influenza viruses as well as influenza A (H5N1)viruses. Results can be available within four hours and the system can test multiple samples at once. "The application of the test to detect an emergent influenza virus would be especially important in the early stages of a pandemic," Secretary Leavitt added. "This breakthrough allows for a more timely detection of a pandemic virus, which helps in determining when to begin broad control strategies as well as life-saving mitigation measures, such as closing schools, cancelling social gatherings and informing businesses to begin work-at-home policies."